Cetirizina GAL

Información principal

  • Denominación comercial:
  • Cetirizina GAL 10 mg
  • Dosis:
  • 10,0 mg
  • formulario farmacéutico:
  • Tableta
  • Usar para:
  • Humanos
  • Tipo de medicina:
  • medicamento alopático

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Localización

  • Disponible en:
  • Cetirizina GAL  10 mg
    Cuba
  • Idioma:
  • español

Otros datos

Estado

  • Fuente:
  • CECMED - Autoridad Reguladora de Medicamentos, Equipos y Dispositivos Médicos - Cuba
  • Número de autorización:
  • 011-15d3
  • última actualización:
  • 09-05-2018

Ficha Técnica

RESUMEN DE LAS CARACTERÍSTICAS DEL PRODUCTO

Nombre del producto:

Cetirizina GAL® 10 mg

Forma farmacéutica:

Tableta

Fortaleza:

10 mg

Presentación:

Estuche por 1 blíster PVC ámbar/AL con 25

tabletas.

Titular del Registro Sanitario, país:

Laboratorios López, S.A. de C.V., San Salvador, El

Salvador.

Fabricante, país:

Laboratorios López, S.A. de C.V., San Salvador, El

Salvador.

Número de Registro Sanitario:

011-15D3

Fecha de Inscripción:

20 de febrero de 2015.

Composición:

Cada tableta contiene:

Cetirizina dihidrocloruro

10,0 mg

Plazo de validez:

24 meses

Condiciones de almacenamiento:

Almacenar por debajo de 30 ºC.

Indicaciones terapéuticas:

Indicado para el alivio de los síntomas de la rinitis alérgica estacional y perenne, conjuntivitis

alérgica,

dermatitis

atópica,

urticaria

crónica

idiopática,

picaduras

insectos

otras

patologías cutáneas que cursen con prurito.

Profilaxis para pacientes asmáticos con componente alérgico.

Contraindicaciones:

Aunque no hay datos que reporten embriotoxicidad, es conveniente como todo medicamento

evitar su uso durante el embarazo, sobre todo en el primer trimestre y durante la lactancia.

Hipersensibilidad a cualquiera de los componentes de la fórmula, pacientes con insuficiencia

renal.

No está indicado en menores de 6 meses

Precauciones:

Se recomienda precaución en pacientes epilépticos y pacientes con riesgo de convulsiones.

Advertencias especiales y precauciones de uso:

No se recomienda el uso de la formulación en tabletas en niños menores de 6 años, ya que

no permite realizar ajustes apropiados de la dosis.

Efectos indeseables:

Estudios clínicos han demostrado que cetirizina a la dosis recomendada tiene efectos

secundarios menores sobre el SNC, incluyendo somnolencia, fatiga, mareo y dolor de

cabeza.

Posología y método de administración:

Vía de administración: Oral

Adultos y niños mayores de 12 años: 1 tableta de 10 mg al día.

Interacción con otros productos medicinales y otras formas de interacción:

La cetirizina experimenta un metabolismo hepático mínimo y se excreta prácticamente

sin alterar. Por este motivo, tiene la ventaja que no interviene con la farmacocinética de

otros medicamentos como: pseudoefedrina, azitromicina, ketoconazol, eritromicina y

teofilina, por su bajo potencial de interactuar con drogas metabolizadas por el citocromo

P450, por lo que puede utilizarse simultáneamente con estas medicamentos. Así, la

administración de cimetidina (un fármaco que interacciona con muchos otros fármacos)

durante 10 días no afectó la farmacocinética de una dosis única de cetirizina.

No interacciona o potencializa los efectos del alcohol.

La cetirizina tiene pocos efectos sobre los receptores muscarínicos, alfa-adrenérgicos,

dopaminérgicos o serotoninérgicos de manera que no son de prever interacciones con

fármacos que actúan sobre estos receptores. Sin embargo, pueden producirse efectos

aditivos

administra

cetirizina

concomitantemente

fenotiazinas

otros

antihistamínicos.

Uso en Embarazo y lactancia:

La cetirizina se clasifica dentro de la categoría B de riesgo en embarazo. No se han

comunicado efectos negativos cuando este fármaco se administró durante el embarazo o

la lactancia. Tampoco este fármaco es teratogénico.

Efectos sobre la conducción de vehículos/maquinarias:

algunos

pacientes,

cetirizina

produce

somnolencia,

estos

serán

advertidos en el caso de que deban conducir o manejar maquinaria.

Sobredosis:

Síntomas

Los síntomas observados después de una sobredosis de cetirizina están principalmente

asociados

efectos

sobre

efectos

podrían

sugerir

efecto

anticolinérgico.

efectos

adversos

después

ingesta

menos

veces

dosis

diaria

recomendada son: confusión, diarrea, mareo, fatiga, dolor de cabeza, malestar, midriasis,

prurito,

nerviosismo,

sedación,

somnolencia,

estupor,

taquicardia,

temblor

retención

urinaria.

Tratamiento

No hay un antídoto conocido específico para cetirizina. De producirse, se recomienda un

tratamiento sintomático o de apoyo. El lavado gástrico se podrá realizar tras una ingesta

reciente. La cetirizina no se elimina de forma efectiva por diálisis.

Propiedades farmacodinámicas:

La cetirizina muestra una alta afinidad hacia los receptores H1 de histamina, mientras

que su afinidad hacia los receptores muscarínicos, dopaminérgicos y serotoninérgicos es

menor que la hidroxizina o la terfenadina. En algunos estudios voluntarios en los que se

produjeron

jabones

inyección

histamina,

reducción

inflamación

producida por la cetirizina fue similar a la de la clemastina, hidroxizina y terfenadina. El

mecanismo de acción de estos fármacos es bien conocido. La respuesta inflamatoria al

alergeno implica una serie de mediadores químicos. Inicialmente, los mastocitos liberan

histamina, la que induce una serie adicional de reacciones en otras células. Entre estas

encuentran

fibroblastos

células

epiteliales,

neutrófilos,

eosinófilos,

macrófagos,

plaquetas

linfocitos.

cetirizina

actúa

sobre

algunos

estos

mediadores: así, algunos investigadores sostienen que en los mastocitos reduce las

concentraciones

prostaglandina

leucotrienos.

cetirizina

suprime

migración de los neutrófilos en todas las reacciones en las que interviene el IgE. También

reduce la infiltración de eosinófilos en la mucosa nasal de los pacientes con rinitis

estacional alérgica, igual que en los sujetos con urticaria inducida por factores físicos.

Aunque no afecta la respuesta inmune sí que tiene un efecto sobre la adhesión celular, al

parecer mediante la inhibición del flujo de eosinófilos inducido por el factor activante de

las plaquetas (PAF). Al ser menos lipófila que otros antihistamínicos, la cetirizina penetra

poco

sistema

nervioso

central

como

consecuencia,

incidencia

somnolencia es menor aunque, cuando se produce está relacionada con la dosis.

Propiedades

farmacocinéticas

(Absorción,

distribución,

biotransformación,

eliminación):

La cetirizina se administra por vía oral, mostrando un efecto muy rápido y una acción

prolongada. Después de una dosis oral, las concentraciones plasmáticas máximas se

alcanzan

hora

proporcionales

dosis

administradas.

biodisponibilidad del fármaco no es afectada por la presencia de alimento, aunque este

puede retrasar algo la absorción. La penetración de la cetirizina en el sistema nervioso

central es pequeña y los niveles en el líquido cefalorraquídeo sólo son el 10% de los

correspondientes niveles plasmáticos. En los niños de 2 a 4 años las mismas dosis que

en los adultos (en mg/kg) ocasionan unas concentraciones plasmáticas menores y tardan

más tiempo en alcanzarse. En los pacientes con disfunción renal, las concentraciones

máximas se alcanzan a las 2 horas

La cetirizina experimenta un mínimo metabolismo; aun así en los pacientes con insuficiencia

hepática el perfil farmacocinético se muestra alterado, siendo menor la cantidad de fármaco

sin alterar excretado en la orina y mayores las concentraciones plasmáticas. La semi-vida de

eliminación de la cetirizina es de 6.5 a 10 h en voluntarios sanos. En presencia de una

insuficiencia renal, esta aumenta hasta las 20 h; además, el aclaramiento global es reducido

Se han encontrado pequeñas cantidades de metabolitos no identificados en la orina de los

voluntarios sanos y un metabolito oxidado en la sangre y en las heces.

Aproximadamente el 60% de una dosis de 10 mg de cetirizina es eliminada en la orina de 24

horas, siendo fármaco nativo en un 80%. En total, la recuperación del fármaco es del 70%

en la orina y del 10% en las heces. La hemodiálisis elimina menos del 10% de la dosis

Instrucciones de uso, manipulación y destrucción del remanente no utilizable del

producto:

La eliminación del medicamento no utilizado y de los materiales que hayan estado en

contacto con él, se hará de acuerdo a la normativa local.

Fecha de aprobación/ revisión del texto: 20 de febrero de 2015.

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